The Recall Desk
HighFDA (Drugs)·D-0119-2026·Announced 2025-11-05

Semaglutide Injection Recalled for Lack of Sterility Assurance

ProRx LLC is recalling 2,805 vials of Semaglutide Injection (5 mg/2 mL) due to lack of assurance of sterility. The affected lot was distributed in Texas and Utah.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall without reported illnesses, injuries, or hospitalization. The hazard is theoretical—potential for contamination—placing it at Score 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ProRx LLC is recalling Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL) multidose vial (NDC 84139-225-02). The recall affects 2,805 vials of lot PRORX052125-4, which was distributed in Texas and Utah.

The recall was issued because the manufacturer cannot provide adequate assurance that the product meets sterility standards. Semaglutide is an injectable medication administered by subcutaneous injection, and sterility is essential to prevent contamination.

Patients who have used product from this lot should contact their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacists should stop dispensing the product and contact ProRx LLC for return and disposal instructions through appropriate pharmaceutical waste channels.

The recalled product

Product
Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
Manufacturer
ProRx LLC
Category
Drug — Injectable / Semaglutide
Hazard
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot PRORX052125-4

Distribution

Distributed in 2 states:

  • TX
  • UT

Related recalls

Same category